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All Rights Reserved, Health Sciences Authority 1
Medical Device Pre-Market Consultation &
Priority Review Scheme13 July 2017 (Thursday)
Medical Devices BranchHealth Products Regulation Group
Health Sciences Authority
All Rights Reserved, Health Sciences Authority 2
ScopeBackground
• Medical Device Development Consultation• Medical Device Pre-submission Consultation• How to schedule an appointment• What to prepare for the appointment
Pre-market Consultation (PMC) Scheme
• Qualification Criteria & Priority Review Scheme Routes• Fees and Turn-Around-Time• How to apply for the scheme• What to submit for the scheme
Priority Review Scheme
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BackgroundCommittee on the Future Economy (CFE) Recommendations
Support Innovation and Device Development Locally● Engage researchers and developers● Enable better understanding of regulatory requirements at early stage of
device development
Facilitate timely access for Medical Devices that demonstrate the potential to address unmet clinical needs
To differentiate HSA as a trusted regulatory leader to help local enterprises expand overseas
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Background
HSA’s Initiatives
1. Pre-Market Consultation Scheme
Support innovation and device development by ensuring devices
are in line with regulatory requirements
2. Priority Review Scheme
Facilitate timely access for devices that address unmet clinical needs
To provide support through the device development lifecycle
DISCOVERY + IDEATION
DEVELOP + PRE-
CLINICALCLINICAL
POST –MARKET
MONITORING
REGULATORYSUBMISSION
PRODUCT
LAUNCH
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MEDICAL DEVICE PRE-MARKET CONSULTATION (PMC) SCHEME
Support innovation and device development
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Pre-Market Consultation (PMC) Scheme
DISCOVERY + IDEATION
DEVELOP + PRE-
CLINICALCLINICAL
POST –MARKET
MONITORING
REGULATORYSUBMISSION
PRODUCT
LAUNCH
Channel for stakeholdersto seek regulatoryadvice during medicaldevice developmentphase to align withregulatory requirements.
Medical Device Development Consultation1
Channel for stakeholders toseek feedback on their devicedossier, prior to pre-marketsubmission in terms ofcompleteness andappropriateness of supportingdocuments.
Medical DevicePre-submissionConsultation2
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1. Medical Device Development Consultation
SCOPE: Clarification on regulatoryrequirements applicable to the devicein development, which may include
• Regulatory strategy
• Regulatory requirements– Device claims – Safety / Performance studies– Sterility– Biocompatibility– Risk management– Clinical trials
DISCOVERY + IDEATION
DEVELOP + PRE-
CLINICALCLINICAL
POST –MARKET
MONITORING
REGULATORYSUBMISSION
PRODUCT
LAUNCH
Channel for stakeholdersto seek regulatoryadvice during medicaldevice developmentphase to align withregulatory requirements.
Medical Device Development Consultation1
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What it is not
1. Medical Device Development Consultation
Medical device developers, researchers
WhoAny time during device development
When For 1 specific device or a group of devices intended to be used together
What
Endorsement of any validation plans, test protocols and/or results that were discussed in the consultation
Does not guarantee approval or marketing clearance
Not meant to be an iterative process
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2. Medical Device Pre-Submission Consultation
SCOPE: Seek feedback on thedevice dossier, in accordance toprescribed Common SubmissionDossier Template (CSDT)guidance template, which mayinclude
• Risk Classification• Registration Route• Grouping• Technical & administrative
documents
DISCOVERY + IDEATION
DEVELOP + PRE-
CLINICALCLINICAL
POST –MARKET
MONITORING
REGULATORYSUBMISSION
PRODUCT
LAUNCH
Medical DevicePre-submissionConsultation2Channel for stakeholders toseek feedback on their devicedossier, prior to pre-marketsubmission in terms ofcompleteness andappropriateness of supportingdocuments.
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2. Medical Device Pre-Submission Consultation
Stakeholders submitting medical devices for registration locally
WhoBefore submission of pre-market application to HSA
WhenDevices to be registered in 1 single pre-market application
What
What it is notNot a scientific evaluation of the device
Does not guarantee regulatory approval or marketing clearance
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Session Duration & Fees
Consultation Category Fees Duration per
session*
Medical Device Development Consultation
$500per device
per consultation Up to 2 hours
Medical Device Pre-submission
Consultation
$200 per device application
per consultation Up to 1 hour
* Refers to only face-to-face meet-up consultation session.
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Process & Timeline
1. Appointment booking
Slots are available forbooking on the onlineAppointment BookingSystem 5 months beforethe appointment date.
E.g. on 1 August 2017,applicants will be able to bookappointments till 31 December2017.
2. Document Submission
ALL required documents30 days beforeappointment date.
Failure to submit requireddocuments by the due datemay result in reschedulingor cancellation of theappointment.
Request for Information
Upon submission, HSA willreview the documents and mayrequest for furtherinformation or clarification viaemail before the appointment,where necessary.
Failure to respond or addressdeficiencies by the stipulatedperiod may result inrescheduling or cancellationof the appointment.
●●●5 Months before ≥ 30 Days before Appointment Date
No extension of due date is permitted. Only ONE rescheduling is allowed per booking reference.
Fees paid are non-refundable.
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Step 1: Appointment BookingAppointment can be made via the online AppointmentBooking System at the following url:
Note:• No CRIS / SingPass / CorpPass login is required.• Ensure all contact details are keyed in accurately as that
will be the only form of verification upon payment andbooking confirmation.
http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Medical_Devices/Regulatory_Updates/md_initiatives.html (accessible upon launch date)
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Step 1: Appointment Booking1. APPLICANT INFO - Enter your particulars and contact details andclick “Next”
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(1) Select Consultation Type and Device Type(2) Select preferred appointment date based on availability (3) Select preferred timeslot(4) Add bookingFor multiple bookings in a single application, repeat steps (1) to (4)
Step 1: Appointment Booking
(3)(4)
(1)
2. BOOKING INFO
(2)
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Step 1: Appointment BookingUpon addition of all required bookings into the list (i), please click“Next” (ii) for confirmation.
(i)
(ii)
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Step 1: Appointment Booking3. CONFIRMATION - Verify applicant & booking details are accuratebefore clicking “Submit”.
REMINDER:Ensure that you areable to provide withrelevant informationrequired for theconsultation 30 daysbefore the selecteddate as fees paid arenon-refundable.
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Step 1: Appointment BookingProceed to complete payment.
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Step 1: Appointment Booking• Each appointment will be issued with a unique booking reference number.• A confirmation email will be sent out for each appointment upon successful
booking.
• An invoice will be generated. Please ‘Save’ or ‘Print’ the invoice if requiredas it will not be retrievable subsequently.
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Step 1: Appointment BookingRecords of booking can be retrieved from the system through theAppointment Booking Inquiry form with either your contact details orbooking reference number
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Step 2: Document Submission• Submit the following information at least 30 days before the scheduled
consultation:(a) Completed consultation form(b) Relevant information described in the form
• Information to be provided by replying to the confirmation email, or email [email protected] and quote the appointment booking referencenumber.
• The respective consultation form(s) can be downloaded from HSA website.Instructions will be provided in the confirmation email and forms.
Reminder:• Incomplete or insufficient information may result in rescheduling or
cancellation of the appointment.• Only ONE rescheduling is allowed per booking reference. Fees paid are not
refundable.
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Step 2: Document Submission(a) Medical Device DevelopmentConsultation Form Proposed agenda Brief device information Overview of device development
status
+(b) Supporting documents* inrelation to the areas to be discussed.Information can be provided inpreferred format, e.g. PowerPointslides, summary copies etc.
* Please ensure that the supporting information isappropriate and relevant to the questions onhand. Please avoid submission of extraneousinformation.
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Step 2: Document Submission(a) Medical Device DevelopmentConsultation Form Proposed agenda Brief device information Overview of device development
status
+(b) Supporting documents* inrelation to the areas to be discussed.Information can be provided inpreferred format, e.g. PowerPointslides, summary copies etc.
* Please ensure that the supporting information isappropriate and relevant to the questions onhand. Please avoid submission of extraneousinformation.
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Step 2: Document Submission(a) Medical Device Pre-SubmissionConsultation Form Device information Application information
+(b) Complete device dossier perCSDT guidance template* based onselected risk class and evaluationroute
* Reference guidance documents:• GN‐15: Guidance on Medical Device Product
Registration• GN‐17: Guidance on Preparation of a Product
Registration Submission for General Medical Devicesusing the ASEAN CSDT
• GN‐18: Guidance on Preparation of a ProductRegistration Submission for In Vitro Diagnostic (IVD)Medical Devices using the ASEAN CSDT
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Pre-Market Consultation (PMC) Scheme
Following are examples of queries which do not require PMC :
• General questions regarding registration procedures or documentaryrequirements for product registration.
• Clarification on the guidance documents on the website.• To seek advice on the risk classification or grouping.• During the review process of a product registration.• To appeal a decision made during pre-market submission.
These enquiries can be sent as general enquiries / using dedicatedenquiry form(s) to [email protected], or to contact officer incharge for clarification related to specific application.
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MEDICAL DEVICE PRIORITY REVIEW SCHEME
Facilitate timely access for Medical Devices that demonstrate the potential to address unmet clinical needs
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Medical devices* to be registered via FULL Evaluation Route
Qualification Criteria
* Class A and devices incorporating registrable medicinal products are not eligible forthe Priority Review Scheme.
Falls under 1 of the5 healthcare focus area
• Cancer• Diabetes• Ophthalmic diseases• Cardiovascular diseases• Infectious diseases
Designed & validated tomeet unmet clinical needs
Intended for a medical purpose with noexisting alternative treatment or meansof diagnosis
ORRepresents a breakthrough technologythat provides a clinically meaningfuladvantage over existing legally marketedtechnology
1 2
Route 1
Route 2
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Turn-Around-Time (TAT) & Fees
Risk Class
TAT (in working days) Evaluation Fee ($)
Route 1 & 2 Route 1 Route 2
25% reduction by mid 2018
35% reduction by end 2019
15% increase over current fee
50% increase over current fee
Class B (FULL) 120 105 4,100 5,300
Class C (FULL) 165 145 6,600 8,600
Class D (FULL) 235 205 13,200 17,100
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Application Process Selection to opt for the Priority Review Scheme can be performed whilesubmitting your product registration application in MEDICS*, at:
Procedure to apply for product registration application remain unchanged.Application Guides with step-by-step guidance are available on website.
* MEDICS (Medical Device Information and Communication System) is an online system for companies to submit applications to HSA.
http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/MEDICS_e-Services.html
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(1) Confirm if you would like to opt in for Priority Review Scheme.(2) Confirm if devices meet qualifying criteria ii) and iii).
Select ‘Yes’ for Route 1, ‘No’ for Route 2.If ‘No’ is selected, subsequent fields will be greyed out. Click ‘Save’ to proceed.(3) For Route 1, select the relevant fields under ii) and iii).(4) Click ‘Save’ before proceeding to next section.
Application Process
(4)
(1)
(3)
Make the relevant selection under ‘3. Priority Review Scheme’ section, in the Pre-MarketApplication form.
(2)
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Document Requirements1) Submission requirements for FULL Evaluation Route.
Refer to following guidance documents for details:• GN‐15: Guidance on Medical Device Product Registration• GN‐17: Guidance on Preparation of a Product Registration Submission for General Medical
Devices using the ASEAN CSDT• GN‐18: Guidance on Preparation of a Product Registration Submission for In Vitro Diagnostic
(IVD) Medical Devices using the ASEAN CSDT
2) Justification to substantiate that the device fulfill criteria 2, for PriorityReview Scheme Route 1.
ALL documents to be submitted under ‘7. Dossier & Supporting Document(s)’section in MEDICS.
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Review Process
HSA reviews if devices fulfilall qualification criteria for theselected Priority ReviewScheme Route and mayrequest for furtherinformation or clarificationvia Input Request (IR), wherenecessary.
Request for Information
Upon Submission
No extension of due date is permitted for IRs related to qualification criteria.
Company will be given 2weeks to respond to queriesregarding qualification for thePriority Review Scheme.
Failure to respond oraddress deficiencies mayresult in application beingswitched to normal routeunder non - Priority ReviewScheme.
Submission of Information
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Timeline
Tentative Launch Date:1 Aug 2017
Information of the Pre-Market Consultation and Priority Review Schemewill be available on HSA website below, upon official launch of theschemes:
For enquiries relating to the new schemes, please contact us [email protected] (upon official launch of the schemes)
http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Medical_Devices/Regulatory_Updates/md_initiatives.html